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Ink Align

FDA UDI

Class I (US FDA UDI)

by Flow X-Ray Corp.

Identity

Trade Name
Ink Align FDA UDI
Generic Name
Tattoo ink, dermal FDA UDI
Device Name
Qfix Ink Align, UV Pink, Box of 25 Applicators. Includes 21 gauge surgical grade, sterile hypodermic needles. FDA UDI
Model / Reference
RT-4426-OUVN FDA UDI
Description
Qfix Ink Align, UV Pink, Box of 25 Applicators. Includes 21 gauge surgical grade, sterile hypodermic needles. FDA UDI

Identifiers

Primary DI / UDI-DI
00843696195069 FDA UDI
FDA Product Code
FZZ FDA UDI
GMDN Term
Tattoo ink, dermal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tattoo ink, dermal

Ink Align by Flow X-Ray Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tattoo ink, dermal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flow X-Ray Corp.

Sources (1)

  • FDA UDI 82dac669-c138-4977-baec-e13d3879c49d 33 fields · synced Jun 8, 2026